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GMP

QMS

GLP

Supplier Audits

Drug (DS/DP) - Medical Device - Clinical - Laboratories - Supplements - Cosmetics - Software & Systems

Fixed Cost includes Travel, Hotel, Draft & Final Reports

GMP Publications, FDA, EU, Chinese CFR Handbooks and Training
Medical Device Audit and Training QSR, QMSR and ISO 13485
GMP Training 21 CFR Parts 210/211 and 820
Dietary Supplement GMP Audits and Training
Good Clinical Practice Audit and Training
Good Laboratory Practice Training and Audits
Cosmetic GMP Audit and Training
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Turnkey CAPA Manager and Management Service

Remediation & Gap Analysis:

  • 483 Help!  EIR 483 and Warning Letters - Compliance

  • Gap Analysis & Turn-key GMP / Turn-key GMP​​

  • Procedure Templates & Development

  • Validation Audits - Process & Equipment

  • Remediation, Validation & Gap Analysis Report

  • As-Built Drawing Qualifications & Validation

  • Engineering GMP Evaluation & Analysis Services

  • DEA Controls - Facility Qualifications

  • Facility & Site Qualification Services​

GMP, GLP, GCP and QMS Audit and Auditing Remediation
Retail Good Manufacturing Practice GMP Certificate Program
Supplier GMP Certificate Program for the Retail Market

  • Dietary Supplements & Vitamins

  • Cosmetics & Topicals

  • Protein & Nutrient Bars and Drinks

GMP Certificates supporting your Product Quality & GMP Compliance!
Clinical Audits and Training
Sterile Drug Audits and Training
Drug Manufacturing Audits and Training
Medical Device and Combination Device Audits and Training
GMP Dietary Supplements Audits and Training
Cosmetics Audits and Training
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GxP Audits

 

 

All Subject Matter Experts (SMEs) have the Experience, Training, Education and Background to support your compliance audit and remediation requirements backed by TAG, ASQ and Global Accepted Certifications!

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  • GMP Audits - API/Excipients

  • GLP Audits - QC, Testing and LIMs, 

  • Mock FDA/EMA, PAI, Pre-ISO

  • Vendors, Suppliers and Contractors

  • Pharmaceuticals / Supplements

  • Medical Devices / IVDs

  • Cosmetics

  • Biologics, Blood, Cell, Tissue

  • Validation Audits

  • Engineering Audits

  • Document Audits

  • Clinical Audits

  • Investigator Sites

  • Clinical Data Management

  • Clinical Electronic Systems

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GMP, GLP, GCP and QMS Audit and Auditing Remediation
Remediation

 

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The Auditing Group SMEs have the Experience to assist with your remediation efforts, whether satisfying a 'For-Cause' US FDA 483, Agency Warning Letter, or audit observations, we have the resources and tools to assist with your successful compliance endeavors.

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  • Project Management

  • CAPA Management

  • Procedure Development

  • Protocol Development

  • Design / Build Engineering Analysis

  • As-Built Qualifications

  • Commissioning and Qualifications

  • Validation Services

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Turn-key or Hourly SME Quotes!

Gantt Driven Project Management

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GMP Engineering, GMP, GLP, GCP and QMS Audit and Auditing Remediation
CAPA Manager, Remediation and GMP Audit, Auditing and Remediation
Training

 

 

                            The Auditing Group has                                    teamed up with GMP Boot                                Camps to provide on-site or                              Virtual training for your                                      Employees to satisfy your                                GxP requirements.

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  • Basic 1, 2, or 3-day GMP / QMS for Drug, Medical Device, Cosmetics or Dietary Supplements Training

  • Focused Training Programs - Taylored to your Company's Products, Services or Capabilities - Includes an on-site pre-training Audit of your GXP Compliance for training applicability.

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GMP Boot Camps, GMP, QMS , FDA, Webinars and onsite Training
GMP Boot Camps, GMP, QMS , FDA, Webinars and onsite Training
GMP Publications, FDA, EU, Chinese CFR Handbooks and Training
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group

The Quality Groups

Seeking Partners, Acquisitions & Investors

Contact:  partners@auditing.com

GMP Publications Regulation Handbooks
The Auditing Group GMP, GLP, and ISO Auditing, Training and Remediation Services
FDA.Com The Food and Drug Assistance Association
GMP Supplies and GMP Suppliers
GXP GMP Recruiters
GMP Suppliers and GMP Supplies
GXP Academy and GMP Boot Camps
GXP Academy and GMP Boot Camps
CAPA Manager, CAPA Management, FDA Help, Turnkey QMS, Turnkey GMP
Retail GMP Certifications
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group

Contact:  partners@auditing.com

GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group
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